TETRACXP SYSTEM (SOFTWARE AND SYSTEM GUIDE)— 510(k) K030828

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K030828 for TETRACXP SYSTEM (SOFTWARE AND SYSTEM GUIDE), Substantially Equivalent on 2003-05-21. Applicant: Beckman Coulter, Inc..

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code GKZ
Advisory panel: Hematology
Date received: 2003-03-14
Decision date: 2003-05-21
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GKZ

product code GKZ

Malfunction: 1,205
Total: 1,205

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.